Birthing simulation devices, systems, and methods

ABSTRACT

Devices, systems, and methods appropriate for use in medical training are disclosed. In some instances, a patient simulator system is provided that includes a maternal patient simulator and a fetal patient simulator. The maternal patient simulator includes an internal chamber sized to receive the fetal patient simulator and a birthing mechanism disposed within the internal chamber configured to translate and rotate the fetal patient simulator with respect to the maternal patient simulator to simulate a birth. In some instances, the maternal patient simulator includes a structural framework and a sub-layer engaged with the structural framework to provide structural support and alignment features for one or more soft silicon outer layers defining a realistic skin of the maternal patient simulator.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/355,982 filed Nov. 18, 2016, which is a continuation of U.S.patent application Ser. No. 14/213,962 filed Mar. 14, 2014, now U.S.Pat. No. 9,501,953, which claims priority to and the benefit of U.S.Provisional Patent Application No. 61/801,714 filed Mar. 15, 2013, eachof which is hereby incorporated by reference in its entirety.

BACKGROUND

As medical science has progressed, it has become increasingly importantto provide non-human interactive formats for teaching patient care.While it is desirable to train medical personnel in patient careprotocols before allowing contact with real patients, textbooks andflash cards lack the important benefits to students that can be attainedfrom hands-on practice. On the other hand, allowing inexperiencedstudents to perform medical procedures on actual patients that wouldallow for the hands-on practice cannot be considered a viablealternative because of the inherent risk to the patient. Non-humaninteractive devices and systems can be used to teach the skills neededto successfully identify and treat various patient conditions withoutputting actual patients at risk.

For example, patient care education has often been taught using medicalinstruments to perform patient care activity on a simulator, such as amanikin. Such training devices and systems can be used by medicalpersonnel and medical students to teach and assess competencies such aspatient care, medical knowledge, practice based learning andimprovement, systems based practice, professionalism, and communication.The training devices and systems can also be used by patients to learnthe proper way to perform self-examinations.

While existing simulators have been adequate in many respects, they havenot been adequate in all respects. Therefore, what is needed is aninteractive education system for use in conducting patient care trainingsessions that is even more realistic and/or includes additionalsimulated features.

SUMMARY

Devices, systems, and methods appropriate for use in medical trainingusing a patient simulator are disclosed. In some instances, a patientsimulator system is provided that includes a maternal patient simulatorand a fetal patient simulator. The maternal patient simulator includesan internal chamber sized to receive the fetal patient simulator and abirthing mechanism disposed within the internal chamber configured totranslate and rotate the fetal patient simulator with respect to thematernal patient simulator to simulate a birth. In some instances, thematernal patient simulator includes a structural framework and asub-layer engaged with the structural framework to provide structuralsupport and alignment features for one or more soft silicon outer layersdefining a realistic skin of the maternal patient simulator.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory innature and are intended to provide an understanding of the presentdisclosure without limiting the scope of the present disclosure. In thatregard, additional aspects, features, and advantages of the presentdisclosure will be apparent to one skilled in the art from the followingdetailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate embodiments of the devices andmethods disclosed herein and together with the description, serve toexplain the principles of the present disclosure.

FIG. 1 is a perspective view of an exemplary maternal patient simulatoraccording to an embodiment of the present disclosure.

FIG. 2 is a side view of the maternal patient simulator of FIG. 1.

FIG. 3 is a front view of the maternal patient simulator of FIGS. 1 and2.

FIG. 4 is a front view of the maternal patient simulator of FIGS. 1-3,but with an outer section of simulator removed to reveal an internalchamber.

FIG. 5 is a close up front view of the maternal patient simulator ofFIGS. 1-4 with the outer section of simulator removed to reveal theinternal chamber.

FIG. 6 is a perspective, partially transparent view of a portion of thematernal patient simulator of FIGS. 1-5 showing aspects of a birthingmechanism disposed within the internal chamber of the maternal patientsimulator according to an embodiment of the present disclosure.

FIG. 7 is a perspective view of the birthing mechanism of FIG. 6.

FIG. 8 is another perspective view of the birthing mechanism of FIGS. 6and 7.

FIG. 9 is a perspective view of a fetal patient simulator engaged withthe birthing mechanism of FIGS. 6-8 according to an embodiment of thepresent disclosure.

FIG. 10 is a perspective, partially transparent view of the fetalpatient simulator of FIG. 9 engaged with the birthing mechanism of FIGS.6-9.

FIG. 11 is a perspective view of the fetal patient simulator engagedwith the birthing mechanism and disposed within the internal chamber ofthe maternal patient simulator according to an embodiment of the presentdisclosure.

FIG. 12 is a perspective view of an exemplary maternal patient simulatoraccording to an embodiment of the present disclosure.

FIG. 13 is a side view of the maternal patient simulator of FIG. 1.

Each of FIGS. 14-17 provides a perspective view of a structuralframework of the maternal patient simulator of FIGS. 1-6 along with thebirthing mechanism of FIGS. 6-11 according to an embodiment of thepresent disclosure.

Each of FIGS. 18-21 provides a perspective view of the structuralframework FIGS. 14-17 with an additional sub-layer engaged therewithaccording to an embodiment of the present disclosure.

FIG. 22 is a side, partially transparent view of a portion of thematernal patient simulator of FIGS. 1-6 according to an embodiment ofthe present disclosure.

FIG. 23 is a perspective view of components of a hip joint of thematernal patient simulator of FIGS. 1-6 according to an embodiment ofthe present disclosure.

FIG. 24 is a perspective view of a hip joint of the maternal patientsimulator of FIGS. 1-6 according to an embodiment of the presentdisclosure.

FIG. 25 is a perspective view of the hip joint of FIG. 24.

FIG. 26 is a front view of a fetal patient simulator according to anembodiment of the present disclosure.

FIG. 27 is a perspective view of the fetal patient simulator of FIG. 26.

FIG. 28 is a side, partially transparent view of the fetal patientsimulator of FIGS. 26 and 27.

FIG. 29 is a perspective view of inner components of the fetal patientsimulator of FIGS. 26-28.

FIG. 30 is a perspective view of the inner components of the fetalpatient simulator shown in FIG. 29.

FIG. 31 is a cross-sectional side view of the inner components of thefetal patient simulator shown in FIGS. 29 and 30.

FIG. 32 is a perspective view of a spinal structure of the fetal patientsimulator of FIGS. 26-31 according to an embodiment of the presentdisclosure.

FIG. 33 is a side view of the spinal structure of FIG. 32.

FIG. 34 is a front view of a joint of the spinal structure of FIGS. 32and 33 that includes an encoder.

FIG. 35 is a front view of a joint of the spinal structure of FIGS. 32and 33 that does not include an encoder.

FIG. 36 is a perspective view of a partially assembled fetal patientsimulator according to an embodiment of the present disclosure.

FIG. 37 is another perspective view of the partially assembled fetalpatient simulator of FIG. 36.

FIG. 38 is a perspective, partially transparent view of a lockingmechanism of the fetal patient simulator of FIGS. 27-31 engaged with astiffening rod according to an embodiment of the present disclosure.

FIG. 39 is a side, partially transparent view of the locking mechanismand stiffening rod of FIG. 38.

FIG. 40 is a top, partially transparent view of the locking mechanismand stiffening rod of FIGS. 38 and 39.

FIG. 41 is a perspective view of a section of inner components of thefetal patient simulator of FIGS. 26-31 showing aspects of the arms ofthe fetal patient simulator according to an embodiment of the presentdisclosure.

FIG. 42 is a perspective view of a section of inner components of thefetal patient simulator of FIGS. 26-31 showing aspects of the legs ofthe fetal patient simulator according to an embodiment of the presentdisclosure.

FIG. 43 is a perspective view of an elbow or knee joint of a fetalpatient simulator according to an embodiment of the present disclosure.

FIG. 44 is a perspective view of the elbow or knee joint of FIG. 43shown in an extended configuration.

FIG. 45 is a side, cross-sectional view of a head of the fetal patientsimulator of FIGS. 26-31 with the head in a neutral position.

FIG. 46 is a side, cross-sectional view of the head of FIG. 45, butshowing the head in a raised position.

FIG. 47 is a perspective view of a torso of the fetal patient simulatorof FIGS. 26-31 shown with an umbilical cord configured to be attached toa belly button of the fetal patient simulator according to an embodimentof the present disclosure.

FIG. 48 is a perspective view of the torso and umbilical cord of FIG.47, but with the umbilical attached to the belly button of the fetalpatient simulator.

FIG. 49 is a perspective view of a foot of the fetal patient simulatorof FIGS. 26-31 according to an embodiment of the present disclosure.

FIG. 50 is a perspective view of the foot of FIG. 49 with a plug coverremoved.

FIG. 51 is a perspective, partially transparent view of the foot ofFIGS. 49 and 50 showing a communication and/or power port disposedtherein according to an embodiment of the present disclosure.

FIG. 52 is a bottom view of the foot of FIGS. 49-51 with the plug coverin place.

FIG. 53 is a bottom view of the foot of FIGS. 49-52 with the plug coverremoved to provide access to the communication and/or power port.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, instruments, methods, and anyfurther application of the principles of the present disclosure arefully contemplated as would normally occur to one skilled in the art towhich the disclosure relates. In particular, it is fully contemplatedthat the features, components, and/or steps described with respect toone embodiment may be combined with the features, components, and/orsteps described with respect to other embodiments of the presentdisclosure. For the sake of brevity, however, the numerous iterations ofthese combinations will not be described separately. For simplicity, insome instances the same reference numbers are used throughout thedrawings to refer to the same or like parts.

One of the aims of healthcare simulation is to establish a teachingenvironment that closely mimics key clinical cases in a reproduciblemanner. The introduction of high fidelity tetherless simulators, such asthose available from Gaumard Scientific Company, Inc., over the past fewyears has proven to be a significant advance in creating realisticteaching environments. The present disclosure is directed to a patientsimulator system that expands the functionality of the simulators byincreasing the realism of the look, feel, and functionality of thesimulators that can be used to train medical personnel in a variety ofclinical situations. The patient simulator systems disclosed hereinoffers a training platform on which team-building scenarios can beperformed for the development of medical treatment skills and theadvancement of patient safety.

In particular, the patient simulator system disclosed herein includes amaternal patient simulator and associated fetal patient simulator thathave improved realism and functionality compared to previously availablesimulators. Some of the various features that facilitate the improvedrealism and functionality are described in detail below. The patientsimulator systems of the present disclosure allow users to practice arange of different simulated birthing scenarios. Thus, the patientsimulator system facilitates the training of user's across the range ofbirthing scenarios and corresponding assessment of the user's responseto the different simulated birthing scenarios. Accordingly, the user'smedical treatment skills can be obtained and/or improved in a simulatedenvironment without endangering a live patient.

Moreover, the patient simulator system allows for multiple users tosimultaneously work with the patient simulator during a particularbirthing scenario, thereby facilitating team training and assessment ina realistic, team-based environment. By allowing multiple users tosimultaneously interact with the patient simulator system, the systemfacilitates the real-time training and assessment of the cooperativeefforts of an OB/GYN team in a wide variety of birthing scenarios andpatient safety scenarios, such as, by way of non-limiting example, afire in the hospital. In some embodiments, the patient simulator systemprovides for pre-operative care simulation as well as post-operativecare simulation, thereby allowing users to experience, address, andassess pre-operative and post-operative management, includingpre-operative acquisition of the patient history and management ofpost-operative complications.

For example, in some embodiments, the patient simulator system allowsfor the realistic reception and transport of the patient simulatorthrough a hospital (e.g., from an emergency room to an operating room)during operation of a particular birthing scenario. In addition, thepatient simulator systems can be used to conduct patient safety drillsin an actual hospital or other medical setting.

In some embodiments, the patient simulator system includes featuresdesigned to enhance the educational experience. For example, in someembodiments, the system includes a processing module to simulatedifferent medical and/or surgical scenarios during operation of thepatient simulator system. In some embodiments, the system includes acamera system that allows visualization of the procedure for real-timevideo and log capture for debriefing purposes. In some embodiments, thepatient simulator system is provided with a workbook of medicalscenarios that are pre-programmed in an interactive software package,thereby providing a platform on which team-building scenarios can beperformed for the development of medical treatment skills and generalpatient safety. Thus, the patient simulator system disclosed hereinprovides a system that is readily expandable and updatable without largeexpense and that enables users to learn comprehensive medical andsurgical skills through “hands-on” training, without sacrificing theexperience gained by users in using standard surgical instruments in asimulated patient treatment situation.

FIGS. 1 and 12 are perspective views of a patient simulator system 100according to one embodiment of the present disclosure. The patientsimulator system 100 includes a maternal patient simulator 110. Thematernal patient simulator 110 includes or is configured to interfacewith a fetal patient simulator, as discussed below, to simulate birthingscenarios. In some embodiments, the patient simulator 110 is tetherless.That is, the patient simulator 110 is functional without wired ortubular connection to other devices outside of the body and, therefore,does not require wires, tubes, or other lines extending from the patientsimulator 110 in order to be fully functional. Rather, the patientsimulator 110 is self-contained. Thus, the patient simulator 110 caninclude an internal power supply, such as a rechargeable power cell, andall pneumatic and fluid connections are made to the correspondingcompressors or other devices within the patient simulator 110. As thepatient simulator 110 is self-contained, it is not only portable, butcan be in use while being transported between different locations.Further, in such embodiments, the patient simulator 110 may communicatewith other devices, such as a control interface, through wirelesscommunication. Thus, the entire simulator system can be functional up tothe limits of the wireless communication. Further, in some embodimentsthe patient simulator 110 connects wirelessly to a processing system,which in some instances includes a computer or network system, whichthen connects to other remote devices via a wired or wireless network,making the functional distance of the patient simulator system 100, andin particular the patient simulator 110, virtually limitless. Inalternative embodiments, the patient simulator 110 is operable intethered and tetherless configurations.

As shown in FIGS. 1-3, 12, and 13, the maternal patient simulator 110comprises a female patient simulator. It is understood that theillustrated embodiment of the maternal patient simulator 110 is sizedand shaped to represent a pregnant female carrying a fetus with agestational age between about 20 weeks and 42 weeks. In that regard, thepatient simulator can take a variety of forms, including a manikin sizedand shaped to represent patients of any size, age, nationality, and/orhealth. Further, the maternal patient simulator 110 may include only aportion of the simulated patient (e.g., specific body parts orcombinations of body parts). For example, in some implementations, thematernal patient simulator includes a torso without a head, arms, and/orlegs. Generally, the combination of anatomical parts may be selectedbased on the particular type(s) of training that the patient simulatoris intended to be used for. In that regard, while it is generallydesirable to have a full patient simulator to enhance realism, due toportability, costs, and/or other factors in some implementations tasktrainers having only the most necessary anatomical parts are utilized.

Further, in some instances, the maternal patient simulator 110 includesa simulated circulatory system, a simulated respiratory system, and/orother simulated aspects. In that regard, the maternal patient simulator110 is in communication with a control system configured to control thecirculatory system, respiratory system, and/or other aspects of thepatient simulator. For example, in some instances, the control system isconfigured to adjust parameters associated with the circulatory system,respiratory system, and/or other aspects of the maternal patientsimulator 110 in accordance with a simulation scenario and/or a user'sapplication of treatment to the maternal patient simulator 110 based onthe simulation scenario. Further, in some instances the circulatorysystem, respiratory system, and/or other aspects of the maternal patientsimulator are affected by the circulatory system, respiratory system,and/or other aspects of the fetal patient simulator.

To that end, in some embodiments the processing system providesphysiological algorithms that are modeled on concurrent differentialequations to provide autonomous or semi-autonomous control of thematernal and/or fetal patient simulators' vital signs. In that regard,in many instances the physiological modeling is executed without theneed for substantial input or direction from the facilitator or user incontrol of the simulator system 100. Rather, in many instances, thefacilitator or user in control of the simulator need only actuate aparticular scenario through a user-interface (e.g., clicking on asimulated button for the particular physiological scenario on a displayassociated with a computing device) and the physiological models willautomatically control the vital signs of the simulators based on theselected scenario and/or the user's interaction with the simulators(e.g., treatments applied to the simulator(s)). In this regard, aspectsof the present disclosure are configured for use with the simulators andthe related features disclosed in U.S. patent application Ser. No.13/031,087, which is hereby incorporated by reference in its entirety.

In some instances, a computer system provides a scenario-based learningplatform on which core surgical competencies can be taught, perfected,and tested. In some instances, the computer system utilizes aninteractive software package containing the scenarios. In someinstances, the patient simulator system 100 includes a workbook ofadvanced scenarios that are pre-programmed in the interactive softwarepackage, thereby providing a platform on which team-building scenarioscan be performed for the development of OB/GYN skills and generalpatient safety. Scenarios can be as simple or complex as desired and cancover an entire procedure, starting from patient presentation, toassessment, to delivery, and ending in the recovery room. Scenarios maybe either pre-programmed or self-constructed (i.e., self-designed).Through the use of either pre-programmed or self-constructed scenarios,the patient simulator system (including the maternal patient simulatorand/or fetal patient simulator) responds appropriately to interventionsand procedures. In some instances, the scenario can cover an entireprocedure. In other instances, the scenarios can cover a portion of asingle procedure or multiple portions of various procedures. In otherinstances, the scenarios can cover a series of complete procedures.

To that end, the patient simulator systems of the present disclosure mayinclude hardware, software, and/or communication features similar tothose described in one or more of U.S. Provisional Patent ApplicationNo. 61/757,143, U.S. patent application Ser. No. 13/752,242, U.S. patentapplication Ser. No. 13/223,020, U.S. patent application Ser. No.13/031,116, U.S. patent application Ser. No. 13/031,087, U.S. patentapplication Ser. No. 13/031,102, U.S. patent application Ser. No.12/856,903, U.S. patent application Ser. No. 12/708,682, U.S. patentapplication Ser. No. 12/708,659, U.S. patent application Ser. No.11/952,606, U.S. patent application Ser. No. 11/952,669, U.S. Pat. Nos.8,016,598, 7,976,313, 7,976,312, 7,866,983, 7,114,954, 7,192,284,7,811,090, 6,758,676, 6,503,087, 6,527,558, 6,443,735, 6,193,519, and5,853,292, and 5,472,345, each herein incorporated by reference in itsentirety.

Further, in some instances, the patient simulator system 100 includesone or more features as provided in medical simulators and associatedsystems provided by Gaumard Scientific Company, Inc. based out of Miami,Fla., including but not limited to the following models: S1000 Hal®,S1020 Hal®, S1030 Hal®, S3000 Hal®, S2000 Susie®, S221 Clinical Chloe,S222 Clinical Chloe, S222.100 Super Chloe, S303 Code Blue®, S304 CodeBlue®, S100 Susie®, S100 Simon®, S200 Susie®, S200 Simon®, S201 Susie®,S201 Simon®, S203 Susie®, S204 Simon®, S205 Simple Simon®, S206 SimpleSusie®, S3004 Pediatric Hal®, S3005 Pediatric Hal®, S3009 Premie Hal®,S3010 Newborn Hal®, S110 Mike®, S110 Michelle®, S150 Mike®, S150Michelle®, S107 Multipurpose Patient Care and CPR Infant Simulator, S117Multipurpose Patient Care and CPR Pediatric Simulator, S157 MultipurposePatient Care and CPR Pediatric Simulator, S575 Noelle®, S565 Noelle®,S560 Noelle®, S555 Noelle®, S550 Noelle®, S550.100 Noelle, and/or otherpatient simulators.

FIGS. 4 and 5 provide front views of the maternal patient simulator 110with an outer section, such as a tummy cover, removed to reveal aninternal chamber 120. The internal chamber 120 is sized and shaped toreceive a fetal patient simulator. In that regard, as shown in FIGS.4-6, the internal chamber 120 also includes a birthing mechanism 130configured to interface with the fetal patient simulator. In thatregard, the birthing mechanism 130 is configured to impart translationaland rotational movement to the fetal patient simulator in order tosimulate a birthing sequence. As best seen in FIG. 6, components of thebirthing mechanism 130 are mounted to a sidewall of the torso of thematernal patient simulator 110. In some instances, such as theillustrated embodiment, the components of the birthing mechanism 130 aremounted in this fashion to allow room for an epidural insert chamber tobe defined in the central portion of the internal chamber 120 adjacentto the back of the maternal patient simulator 110.

FIGS. 7 and 8 show additional features of the birthing mechanism 130. Asshown, the birthing mechanism 130 is an electro-mechanical systemconfigured to impart rotation and translational movement. Further, asshown in FIGS. 9-11, the birthing mechanism is configured to engage witha fetal patient simulator 200. More specifically, in the illustratedembodiments the birthing mechanism 130 includes a locking feature 132that is configured to fixedly engage a stiffening rod. As will bediscussed in greater detail below, the stiffening rod is configured toimpart a rigidity to the spinal structure of the fetal patient simulator200 to allow it to be translated and rotated by the birthing mechanism.In that regard, some of the fetal patient simulators of the presentdisclosure present highly flexible body structure, simulating a naturalnewborn, that the stiffening rod is necessary to facilitate a realisticbirthing simulation because without the stiffening rod the conformalnature of the fetal patient simulator can result in damage to the fetalpatient simulator and/or an unrealistic birthing presentation/sequence.

In some instances, the locking mechanism 132 is a spring-loaded leverthat engages a recess or detent of the stiffening rod to provide amechanical, locking engagement. To that end, in some implementations thestiffening rod is inserted into and engaged with a locking mechanism ofthe fetal patient simulator 200, as described in greater detail below,then the fetal patient simulator 200 and the stiffening rod are insertedinto the internal chamber 120 and a portion of the stiffening rodextending from the fetal patient simulator 200 is engaged with thelocking mechanism 132. With the fetal patient simulator 200 engaged withthe locking mechanism 132 in this manner, a birthing simulation canbegin and the birthing mechanism can impart translational and rotationalmotion to the fetal patient simulator to simulate a natural birthscenario. In that regard, the actual parameters of the birthing scenarioare defined by the control system in some instances.

Referring now to FIGS. 14-17, shown therein is a structural framework140 of the maternal patient simulator 110 according to an embodiment ofthe present disclosure. In that regard, as some embodiments of thematernal patient simulator 110 utilize soft silicon outer layers todefine a realistic skin layer (e.g., using materials from one or more ofthe patents and patent applications incorporated by reference above),the maternal patient simulator 110 has a high degree of flexibility andgive, simulating a natural human body. However, in order to provide arepeatable and reliable birthing simulation, the maternal patientsimulator 110 also includes structural framework 140 formed of a rigidmaterial (e.g., metal (aluminum, stainless steel, sheet metal, etc.) orrigid plastic). In that regard, the structural framework 140 provides arigid structure to which the other components of the maternal patientsimulator 110 can be attached to and/or aligned with. In particular, insome implementations the structural framework 140 is utilized to alignthe birthing mechanism 130 with the birth canal of the maternal patientsimulator 110. Having the birthing mechanism 130 properly alignedprevents unwanted wear and/or stress on the birthing mechanism 130and/or the fetal patient simulator 200 that results from the increasedfriction, stress, and/or bending associated with misalignment.

Referring now to FIGS. 18-21, shown therein is the structural framework140 with another sub-layer 150 of the maternal patient simulator 110engaged therewith. In the illustrated embodiment, the sub-layer 150 isformed vinyl and provides a structural support and/or alignment featuresfor the soft silicon skin layers and/or other components of the maternalpatient simulator 110. For example, in some instances the sub-layer 150includes openings, recesses, projections, and/or other structuralfeatures to facilitate the alignment and assembly of various componentsof the maternal patient simulator. Further, in some instances thesub-layer 150 is formed of a material that is softer than that of thestructural framework 140 and that provides a more realistic feel tointernal structures of a natural human body than that of the structuralframework 140.

Referring now to FIGS. 22-25, shown therein are aspects of a hip jointof the maternal patient simulator 110 according to an embodiment of thepresent disclosure. As shown, the hip joint of the maternal patientsimulator 110 includes a plate 160 that is secured to the torso of thematernal patient simulator 110 and, in particular, the structuralframework 140 and/or the sub-layer 150 in some instances. To provide arealistic hip motion, a flexible tubular member 162 connects the plate160 attached to the torso of the maternal patient simulator 110 to acomponent attached to a leg of the maternal patient simulator 110. Inthat regard, the flexible tubular member 162 is hydraulic tubing in someinstances. For example, in some instances the flexible tubular member isrubber tubing with metal reinforcing mesh to provide sufficientstructural rigidity along the axial length of the tubing to preventcollapsing, but sufficient flexibility to simulate the ball-and-socketmotion of a natural hip joint. In the illustrated embodiment, each endof the flexible tubular member 162 is engaged with a barb 164. Inparticular, the barb 164 is positioned within the inner lumen of thetubular member 162. In some instances, a clamp is positioned around theflexible tubular member 162 and the barb 164 to further secure theflexible tubular member 162 to the barb 164. In order to limit the rangeof motion of the hip joint to a more natural range of motion than theflexible tubular member 162 alone would provide, the hip joint includesone or more tethered connections between the plate 160 and a portion ofthe leg. For example, as shown in FIGS. 24 and 25 four cables 166 areconnected between the plate 160 and the leg of the patient simulator.The lengths of the cables 166 are selected to provide a realistic rangeof motion to the hip joint in the various directions. A similar approachcan be utilized to form the shoulder joints of the maternal patientsimulator 110.

In some implementations, the maternal patient simulator includes adistensible cervix that can be controlled independently of the positionof the fetal simulator. In that regard, previous birthing simulatorshave relied upon the descent of the fetal simulator to cause the cervixto dilate. However, to more realistically simulate various birthingscenarios, the maternal patient simulator 110 includes a cervix wheredilation can be controlled separately from the position of the fetalsimulator. For example, in some implementations the cervix is defined bya flexible material (e.g., silicon) that includes an opening. In thatregard, the size of the opening defines the amount of dilation of thecervix. Accordingly, by selectively increasing (or decreasing) the sizeof the opening the simulated dilation of the cervix is changed. To thatend, in some instances a cord is disposed within the materialsurrounding the opening such that tensioning the cord can be utilized toselectively expand or contract the opening defined by the material. Forexample, in some instances at least one end of the cord is coupled to amotor such that when the motor is actuated in a first direction the cordis tensioned, retracted, and wrapped around a pulley or other member toincrease/decrease the size of the opening. When the motor is actuated ina second direction (opposite of the first direction) and/or the cord isotherwise released from the tensioned, retracted, or wrapped position,the size of the opening decreases/increases accordingly. By selectivelycontrolling actuation of the motor (or other control mechanism) dilationof the cervix can be controlled. Accordingly, in some instances thecontrol system defines the amount of dilation of the cervix for aparticular scenario independent of the descent of the fetal simulatoralong the birth canal.

Referring now to FIGS. 26-53, aspects of the fetal patient simulator 200according to embodiments of the present disclosure will be described. Inthat regard, in addition to the features specifically described below,it is understood that the fetal patient simulator 200 may includefeatures similar to those described with respect to the fetal and/ornewborn patient simulators in the patents and patent applicationsincorporated by reference above, especially the respiratory and/orcirculatory features. However, for sake of brevity these variousfeatures will not be described in detail below.

FIG. 26 provides a front view of the fetal patient simulator 200, whileFIG. 27 provides a perspective view of the fetal patient simulator ofFIG. 26. As shown, the fetal simulator 200 includes a continuous,flexible outer skin layer that covers the internal components of thefetal simulator. More specifically, in some instances the entire outerskin layer other than that associated with the hands and feet of thefetal patient simulator are formed of a single, continuous piece ofsilicon. In some instances, an opening in the single, continuous pieceof silicon that is utilized to insert the internal components of thefetal patient simulator is bonded, glued, and/or otherwise securedtogether along the back or spine of the patient such that the outer skinlayer provides a realistic, continuous skin layer over all but the handsand feet of the patient simulator. To that end, the hands and feet ofthe patient simulator are formed of the same or similar material as themajority of the outer skin layer in some instances. In some instances,the hands and/or feet are formed of a slightly harder material than themajority of the outer skin layer to increase the durability of thoseportions of the fetal patient simulator.

Referring now to FIG. 28-31, shown therein are aspects of the internalcomponents of the fetal patient simulator. More specifically, as shownthe fetal patient simulator 200 includes an internal structure thatincludes an articulating spine formed or a plurality of pivoting joints,articulating arms and legs, and a moveable head assembly. For example,FIGS. 31-35 illustrate aspects of the spine assembly. In that regard,FIG. 31 provides a cross-sectional side view of the inner components ofthe fetal patient simulator, including the spine assembly; FIG. 32 is aperspective view of the spine assembly; FIG. 33 is a side view of thespine assembly; FIG. 34 is a front view of a joint of the spine assemblythat includes an encoder; and FIG. 35 is a front view of a joint of thespinal assembly that does not include an encoder. As shown, the spineassembly includes a plurality of pivoting joints connected together todefine ranges of motion that mimic that of an infant spine, which ishighly flexible and/or floppy in some instances. In order to monitor therelative position(s) of the joints some of the joints include an angleor position encoder, as shown in FIG. 34. Further, in some instances oneor more of the joints includes force or pressure sensor(s) to monitorthe forces being applied to the joints of the fetal patient simulator.The information from the angle/position encoder(s) and/or theforce/pressure sensor(s) can be supplied to the control system andutilized in evaluation of the treatment being applied by the user. Forexample, if the user is putting too much force on the fetal simulator'sneck or spine as a resulting trying to pull the fetal simulator outprematurely and/or improperly attempting to rotate the fetal simulator,then the readings from these sensors will reflect that. Further, theangle/position sensors can be utilized to depict a 3-D representation ofthe fetal simulator on a display of the control system for currentand/or later evaluation by a teacher and/or the user.

FIGS. 36 and 37 provide perspective views of a partially assembled fetalpatient simulator 200 according to an embodiment of the presentdisclosure. As best seen in FIG. 36, the spine assembly includes aplurality of openings extending along the length of the spine that aresized and shaped to receive a stiffening rod. In that regard, because ofthe highly flexible nature of the spine assembly of the fetal patientsimulator 200, a stiffening rod is inserted through the openings in thespine assembly to provide rigidity and alignment to the spine assemblyduring a birthing simulation. In that regard, the stiffening rodprovides sufficient structural rigidity to the fetal simulator 200 toallow the birthing mechanism 130 of the maternal simulator 110 to birththe fetal simulator 200 through the birth canal of the maternalsimulator 110. To that end, the openings in the spine assembly of thefetal patient simulator 200 are aligned (or alignable) with an openingin the bottom of the fetal patient simulator 200 that is configured toreceive the stiffening rod. To that end, FIG. 31 shows the stiffeningrod received within the patient simulator 200, while FIGS. 38-40 showaspects of a locking mechanism of the fetal patient simulator 200 thatis configured to selectively engage the stiffening rod. Morespecifically, as shown in FIGS. 38-40, the locking mechanism includes aspring-biased lever with a projection sized and shaped to engage arecess or detent formed in the outer profile of the stiffening rod suchthat when the projection is engaged with the recess or detent (FIG. 39shows this best) the locking mechanism and, thereby, the fetal simulatoris fixedly engaged with the stiffening rod. In some instances, a portionof the stiffening rod will extend outside of the fetal simulator 200 forengagement with the locking mechanism 130 of the maternal simulator 110(as described above).

The locking mechanism of the fetal patient simulator 200 iselectronically controlled to selectively release the fetal patientsimulator 200 from engagement with the stiffening rod. In that regard,by maintaining engagement of the fetal patient simulator 200 with thestiffening rod a user is prevented from prematurely pulling the fetalpatient simulator 200 from the birth canal during a birthing simulation.Instead, any excess force applied by the user in attempts to prematurelyremove the fetal simulator will be registered by the force/pressuresensor(s) and/or position/angle encoder(s) of the fetal simulator.Further, once the birthing sequence has progressed to a point where thefetal patient simulator 200 can be removed from the maternal simulator110, then the lever of the locking mechanism of the patient simulator200 is removed from engagement with the recess or detent of thestiffening rod. With the locking mechanism of the fetal patientsimulator 200 disengaged from the stiffening rod (and the lockingmechanism of the maternal simulator 110 still engaged with thestiffening rod), the fetal patient simulator 200 can be removed from thematernal simulator 110 at which point the stiffening rod will havepassed through the openings in the spine assembly and out the bottom ofthe fetal simulator 200, such that the spine assembly of the fetalsimulator 200 is no longer held in the rigid, aligned position definedby the stiffening rod. As a result, the fetal simulator 200 exhibits thehighly flexible spinal structure of a typical newborn upon birth. Inthis manner, the system provides sufficient structural definition tofacilitate birthing of the fetal simulator without compromising therealistic, highly flexible nature of the fetal simulator upon birth. Insome instances, the stiffening rod is manually detached from the lockingmechanism 132 of the maternal simulator 110 and reinserted into thefetal simulator 200 prior to the next birthing simulation.

Referring now to FIGS. 41-44, shown therein are aspects of the arms andlegs of the fetal patient simulator 200, including the shoulder, elbow,hip, and knee joints. In that regard, in some instances the shoulderand/or hip joints of the fetal patient simulator 200 are defined by atleast in part by a flexible tubular member, similar to the hip joint ofmaternal simulator 110 described above. However, due to the highlyflexible nature of fetal joints and the smaller mass associated with thecomponents of the arm and leg components of the fetal simulator 200, insome instances the hip and/or shoulder joints are solely defined by theflexible tubing, without the need for tethers to limit the range ofmotion. However, in other instances tethers are utilized in a similarmanner to that described above for the maternal simulator. As shown inFIGS. 43 and 44, the elbow and knee joints of the fetal patientsimulator are configured to provide a realistic range of motion. FIGS.41 and 42 also illustrate that, also similar to maternal simulator 110,the internal support structure of the fetal patient simulator 200includes a sub-layer (similar to sub-layer 150) that is secured tometallic or other rigid structural components of the fetal patientsimulator 200. In some instances the sub-layer is formed vinyl andprovides a structural support and/or alignment features for the softsilicon skin layer and/or other components of the fetal patientsimulator 200. For example, in some instances the components of thesub-layer include openings, recesses, projections, and/or otherstructural features to facilitate the alignment and assembly of variouscomponents of the fetal patient simulator and/or provide realisticanatomical landmarks that can be felt through the outer silicon skinlayer(s). In that regard, in some instances the sub-layer is formed of amaterial that is softer than that of the spine assembly and thatprovides a more realistic feel to internal structures of a naturalnewborn or fetus.

Referring now to FIGS. 45 and 46, shown therein are side,cross-sectional views of a head of the fetal patient simulator 200. Inthat regard, the fetal patient simulator 200 includes an actuatordisposed within the head to facilitate movement of the head. Inparticular, the actuator is configured to selectively raise or lift thehead of the fetal patient simulator 200. To that end,

FIG. 45 shows the head in a neutral position. As shown, a cord or lineextends from the actuator across the space within the head and issecured to a structure inside the head adjacent to the forehead. Asshown in FIG. 46, the head has been moved to raised or lifted positionby the actuator. In that regard, the length of the cord or lineextending between the actuator and the structure inside the headadjacent to the forehead has been shortened causing the head to tilt upor back. In some instances, the actuator is a motor and/or pulley systemthat is configured to selectively retract or wrap the cord/line to causethe head to tilt. By either releasing the cord/line or reversingoperation of the actuator, the head will return to the neutral positionof FIG. 45.

In some instances, the tilting functionality of the head described aboveis utilized to simulate the rise of the fetus's head during a naturalbirth. In that regard, the birthing scenario implemented by the controlsystem can cause the actuator to selectively tilt the head and/or returnto the neutral position at the appropriate times during the birthingsequence to more realistically simulate the natural birthing sequence.In this manner, the natural rise of the fetal simulator can be simulatedwithout needing to account for complicated three-dimensional positioncontrol with the birthing mechanism 130. In other instances, aninflatable bag or other member positioned outside of the fetal simulatorwithin the chamber 120 of the maternal simulator 110 can be selectivelyinflated or actuated to impart a tilt or rise of the head of the fetalsimulator 200 during the birthing sequence.

Referring now to FIGS. 47 and 48, shown therein are aspects of anattachable umbilical cord for use with the fetal patient simulator 200.In that regard, in some implementations the umbilical cord is similarone or more of the umbilical cords described in the patents and patentapplications incorporated by reference above, including various lumenstructures and associated realistic materials. In the illustratedembodiment, the belly button of the fetal patient simulator 200 includesa magnet therein and an end of the umbilical cord configured to beattached to the belly button includes a magnetically attractivematerial, such as suitable metal, such that the umbilical cord can bemagnetically attached to and detached from the belly button of the fetalsimulator. FIG. 48 shows the umbilical cord magnetically attached to thebelly button of the fetal simulator 200.

Referring now to FIGS. 49-53, shown therein are aspects of a foot of thefetal patient simulator 200 according to an embodiment of the presentdisclosure. In particular, FIGS. 49-53 show aspects of a foot thatincludes a communication and/or power port disposed therein for use incommunicating with, programming, updating, and/or charging the internalcomponents of the fetal patient simulator. In that regard, FIGS. 49 and52 show the foot in a fully assembled state with a plug cover in place.As shown, the plug cover provides a relative smooth and continuousbottom surface to the foot. However, the plug cover is removable (asshown in FIGS. 50 and 53 to provide access to the communication and/orpower port disposed within the foot (as shown in FIG. 51). To that end,the communication and/or power port is stand protocol port (e.g., USB)in some implementations. In other implementations, the communicationand/or power port is a custom connector. Further, in some instances, thecommunication and/or power port includes a plurality of ports, which maybe standard, custom, and/or combinations thereof. The communicationsand/or power port is utilized to charge a battery or other power sourceof the fetal patient simulator in some instances. In some instances, thecommunications and/or power port is utilized to reprogram and/or updateaspects of the software or firmware executing inside of the fetalpatient simulator. In other instances, wireless communication isutilized to facilitate communicating with, programming, updating, and/orcharging the internal components of the fetal patient simulator.

Persons of ordinary skill in the art will appreciate that theembodiments encompassed by the present disclosure are not limited to theparticular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. A patient simulator system, comprising: amaternal patient simulator having: an internal chamber sized and shapedto receive a fetal patient simulator; a birthing mechanism disposedwithin the internal chamber, the birthing mechanism configured totranslate and rotate the fetal patient simulator with respect to thematernal patient simulator to simulate a birth; a structural framework;and a sub-layer engaged with the structural framework to providestructural support and alignment features for one or more soft siliconouter layers defining a realistic skin of the maternal patientsimulator.
 2. The patient simulator system of claim 1, wherein thestructural framework at least partially defines the internal chamber inwhich the birthing mechanism is disposed.
 3. The patient simulatorsystem of claim 2, wherein the structural framework is utilized to alignthe birthing mechanism with a birth canal of the maternal patientsimulator.
 4. The patient simulator system of claim 1, wherein thestructural framework is formed of a rigid material.
 5. The patientsimulator system of claim 4, wherein the sub-layer is formed of amaterial that is softer than that of the structural framework and thatprovides a more realistic feel to internal structures of a natural humanbody than that of the structural framework.
 6. The patient simulatorsystem of claim 1, wherein the structural framework and the sub-layer atleast partially define a torso of the maternal patient simulator.
 7. Thepatient simulator system of claim 6, wherein the maternal patientsimulator includes articulating hip joints coupled to the torso of thematernal patient simulator.
 8. The patient simulator system of claim 7,wherein the articulating hip joints include a first plate secured to thetorso of the maternal patient simulator, a second plate secured to a legof the maternal patient simulator, and a flexible tubular memberextending between the first and second plates.
 9. The patient simulatorsystem of claim 8, wherein the articulating hip joints further include aplurality of tethers extending between the first and second plates tolimit relative motion.
 10. The patient simulator system of claim 8,wherein the articulating hip joints further include a sensor formonitoring relative movement of the hip joint.
 11. The patient simulatorsystem of claim 1, wherein the maternal patient simulator includes aremovable tummy cover.
 12. The patient simulator system of claim 11,wherein the removable tummy cover is configured to simulate at least oneof maternal contractions and a fetal heart rate.
 13. The patientsimulator system of claim 12, wherein the removable tummy cover includesat least one speaker for simulating the fetal heart rate.
 14. Thepatient simulator system of claim 12, wherein the removable tummy coverincludes at least one reservoir configured to receive fluid or air,wherein selective introduction and removal of the fluid or air into theat least one reservoir simulates the maternal contractions.